Comparison of Prostate Fusion Biopsies With Software and Cognitive

Not Applicable

• Conditions: Prostate Cancer Detection; Fusion Prostate Biopsy
• Interventions: Diagnostic Test: cognitive vs software

• Registration Number: NCT04291742
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.

Detailed Description

Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.

Study Timeline

• Study Start: 2020-01-16
• Status Verified: 2020-02
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02
• Primary Completion: 2022-02-27
• Study Completion: 2022-02-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 804

Inclusion Criteria

• Age over 40 years.
• mpMRI carried out in our center.
• Presence of lesions with PIRADSv.2 ≥ 3.
• Acceptance to participate in the study.

Exclusion Criteria

• PSA> 30 ng / ml
• Treatment with 5-ARIs (5-alpha-reductase inhibitors).
• Previous diagnosis of PCa.
• TR> T3.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0: cognitive	cognitive vs software	target prostate biopsies by cognitive fusion
1: software	cognitive vs software	target prostate biopsies by software

Primary Outcome Measures

Name	Time	Method
Rate of overall prostate cancer and significant prostate cancer between the groups	2 years	Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed.

Secondary Outcome Measures

Name	Time	Method
Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume.	2 years	Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the prostate volume.
Rate of overall prostate cancer and significant prostate cancer between the groups according to the PIRADS (prostate imaging and reporting and data System) of the lesions.	2 years	Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the PIRADS (prostate imaging and reporting and data System) of the lesions.
Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions.	2 years	Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the location of the lesions.
Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions.	2 years	Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the size of the lesions.

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain